Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d)

STADA Group; Bad Vilbel; Hybrid; EUR 120.000 - 150.000; Vollzeit

Zusammenfassung

A global pharmaceutical company located in Bad Vilbel, Germany, seeks a Senior Director for Regulatory Global Specialty/Biosimilar Development. The ideal candidate will have extensive experience in regulatory affairs within the pharmaceutical industry, including proven success in achieving drug approvals. Responsibilities include overseeing regulatory activities, defining KPIs, and leading a team. The company offers flexible working hours, personal development opportunities, and various additional benefits.

Leistungen

Flexible working hours

Mobile working up to 2 days per week

Childcare allowance

Health-promoting offers

Qualifikationen

• 15+ years of experience in the Pharmaceutical industry.
• 8+ years in Regulatory Affairs including global positions.
• Proven track record of drug approvals.

Aufgaben

• Define roles and responsibilities for team members.
• Oversee regulatory activities and health authority interactions.
• Ensure timely delivery of regulatory documents.

Kenntnisse

Team leadership

Regulatory Affairs expertise

Project management

Biologics knowledge

Regulatory intelligence software

Curiosity and open-mindedness

Strong communication in English

Ausbildung

Master or PhD in Life Science

Tools

eCTD preparation tools

Jobbeschreibung

Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d)

Senior Director Regulatory Global Specialty / Biosimilar Development – Bad Vilbel, Germany – Full‑time, Permanent, Portfolio & Product Development – Professionals.

"Caring for People’s Health as a Trusted Partner" – This purpose motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options. Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

What You Can Expect

• Define clear roles and hono responsibilities and develop individual team members.
• Prioritize and align individual deliverables across the department with overarching objectives.
• Define relevant KPIs for the Regulatory department to consistently track performance. പിtenir
• Oversee all regulatory activities, including contribution to due diligences.
• Prepare for and participate in all regulatory interactions with health authorities.
• Ensure the timely and high‑quality delivery of all regulatory documents for new applications and life‑cycle management activities.
• Closely monitor new regulatory trends, guidance, and guidelines, translating them into impact assessments for Specialty and Biosావేశ business.
• Implement best‑in‑class tools and state‑of‑the‑art processes to support the department.
• Act as a sparring partner for the VP Global Specialty Development in strategic discussions on Specialty & Biosimilar assets.
• Represent Global Specialty/Biosimilar development in management boards.
• Serve as the go‑to expert for all global and local regulatory questions.

Who We Are Looking For

• Master or PhD in Life Science.
• 15+ years of experience in the Pharmaceutical industry and 8+ years of experience in Regulatory Affairs, including global positions.
• Proven track record of achieving drug approvals from different health authorities.
• Broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre‑approval inspections, etc.
• Proven track record as team leader in line or matrix setting.
• Robust understanding of Biologics/recombinant molecules, ideally also Biosimilars.
• Experienced user of regulatory intelligence software, publishing tools and document management software (preparation of eCTDs).
• Team player, proven success in global and cross‑functional environments.
• Entrepreneurial, proactive, agile working style, resilient in facing ambiguity and deploying project management skills.
• Open‑minded, curious to explore new ways of working.
• Excellent knowledge in English; German is a plus.

What We Offer

• Open corporate culture with fast uncertain decision‑making processes and many opportunities for personal_rcdevelopment.
• Individual development and training opportunities.
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile).
• Job ticket for the RMV region and Job Bike.
• Childcare allowance.
• Health‑promoting offers such as Wellpass or STADA Gym (free of charge).
• Numerous additional benefits such as group accident insurance or supplementary pension scheme.
• Subsidised cafeteria.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.

We look forward to receiving your application via our career portal. If you have further questions, please reach out to [e-mail]. We will consider requests to work part‑time on an individual basis.